Hip fracture trials often suffer substantial loss to follow-up due to difficulties locating and communicating with participants or when participants, or their family members, withdraw their consent. We aimed to determine which factors were associated with being unable to contact FAITH and HEALTH participants for their 24-month follow-up and to also determine which factors were associated with their withdrawal of consent.
We conducted 2 multivariable logistic regression analyses to determine which factors were predictive of being unable to contact participants at 24 months postfracture and withdrawal of consent within 24 months of their fracture. Results were reported as odds ratios, 95% confidence intervals, and associated P-values. All tests were 2-tailed with alpha = 0.05.
We were unable to contact 123 of 2520 participants (4.9%) for their 24-month follow-up visits and 124 (4.9%) withdrew their consent from the trial. Being non-White (P = 0.003), enrolled from a non-European hospital (P &lt; 0.001), and treated with arthroplasty (P &lt; 0.001) were associated with an increased odds of not completing the 24-month follow-up visit. Being enrolled from a hospital in the United States (P = 0.02), from a hospital in Oceania, India, or South Africa (P &lt; 0.001) as compared to a European hospital, and treated with arthroplasty (P &lt; 0.001) were associated with an increased odds of consent withdrawal.
Certain factors may be predictive of loss to follow-up in hip fracture trials. We suggest that the identification of such factors may be used to inform and improve retention strategies in future orthopaedic hip fracture trials.
Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.Hip fractures are recognized as one of the most devastating injuries impacting older adults because of the complications that follow. Mortality rates postsurgery can range from 14% to 58% within one year of fracture. We aimed to identify factors associated with increased risk of mortality within 24 months of a femoral neck fracture in patients aged ?50 years enrolled in the FAITH and HEALTH trials.
Two multivariable Cox proportional hazards regressions were used to investigate potential prognostic factors that may be associated with mortality within 90 days and 24 months of hip fracture.
Ninety-one (4.1%) and 304 (13.5%) of 2247 participants died within 90 days and 24 months of suffering a femoral neck fracture, respectively. Older age (P &lt; 0.001), lower body mass index (P = 0.002), American Society of Anesthesiologists (ASA) class III/IV/V (P = 0.004), use of an ambulatory aid before femoral neck fracture (P &lt; 0.001), and kidney disease (P &lt; 0.001) were associated with a higher risk of mortality within 24 months of femoral neck fracture. Older age (P = 0.03), lower body mass index (P = 0.02), use of an ambulatory aid before femoral neck fracture (P &lt; 0.001), and having a comorbidity (P = 0.04) were associated with a higher risk of mortality within 90 days of femoral neck fracture.
Our analysis found that factors that are indicative of a poorer health status were associated with a higher risk of mortality within 24 months of femoral neck fracture. https://www.selleckchem.com/GSK-3.html We did not find a difference in treatment methods (internal fixation vs. joint arthroplasty) on the risk of mortality.
Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.To compare the 24-month risk of mortality between arthroplasty and internal fixation for undisplaced femoral neck fractures (FNFs).
Retrospective cohort study.
Secondary data analysis of 2 multinational randomized controlled trials.
Patients aged 50 years or older with a FNF.
Arthroplasty (n = 1441), including total hip arthroplasty and hemiarthroplasty, performed for a displaced FNF versus internal fixation (n = 734), including sliding hip screw or multiple cancellous screws, performed for an undisplaced FNF.
The primary outcome was mortality within 24 months of injury. Secondary outcomes included reoperation and health-related quality of life.
The 24-month mortality rate was 15.0% (n = 327). Arthroplasty was associated with a significant reduction in the odds of mortality [adjusted odds ratio (aOR) 0.56, 95% confidence interval (CI) 0.44-0.72, P &lt; 0.01] compared with treatment with internal fixation. 11.4% (n = 248) of the study patients required reoperation within 24 months of injury. The odds of reoperation were 59% lower with arthroplasty treatment than with internal fixation (aOR 0.41, 95% CI 0.32-0.55, P &lt; 0.01). The 24-month SF-12 physical component scores were 2.7 points higher in arthroplasty patients compared with internal fixation patients (95% CI 1.6-3.8, P &lt; 0.01).
Our findings suggest arthroplasty for a FNF may reduce the risk of mortality and reoperation compared with internal fixation of undisplaced fractures. This finding is counter to many current surgical practices but consistent with a mounting body of evidence. Before widespread adoption of arthroplasty for undisplaced fractures, these results should be confirmed in a definitive comparative trial.
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.Over the past decade, 2 randomized controlled trials were performed to evaluate 2 surgical strategies (internal fixation and arthroplasty) for the treatment of low-energy femoral neck fractures in patients aged ?50 years. We evaluated whether patient populations in both the FAITH and HEALTH trials had different baseline characteristics and compared the displaced femoral neck fracture cohort from the FAITH trial to HEALTH trial patients.
Patient demographics, medical comorbidities, and fracture characteristics from both trials were compared. FAITH trial patients with displaced fractures were then compared with HEALTH patients. T-tests and χ tests were performed to compare differences for sex, age, osteoporosis status, and ASA class.
The mean age of the 1079 FAITH trial patients was 72 versus 79 years for the 1441 HEALTH trial patients. HEALTH patients were older, mostly White, used more medication, and had more comorbidities than FAITH patients. Of the 1079 FAITH trial patients, 32% (346/1079) had displaced fractures.